Good morning, and welcome to Elanco Animal Health's First Quarter 2023 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the call over to Katy Grissom, Head of Investor Relations. Thank you. Please go ahead.

Good morning. Thank you for joining us for Elanco Animal Health's First Quarter 2023 Earnings Call. I'm Katy Grissom, Head of Investor Relations. Joining me on today's call are Jeff Simmons, our President and Chief Executive Officer; Todd Young, our Chief Financial Officer; and Scott Purucker from Investor Relations. The slides referenced during this call are available in the Investor Relations section of elanco.com. Today's discussion will include forward-looking statements. These statements are based on our current assumptions and expectations and are subject to risks and uncertainties that could cause actual results to differ materially from our forecast. For more information, see the risk factors discussed in today's earnings press release as well as our latest Form 10-K and 10-Q filed with the SEC. We do not undertake any duty to update any forward-looking statements. Our remarks today will focus on non-GAAP financial measures. Reconciliations of these non-GAAP measures are included in the appendix of today's slides and in the earnings press release. After our prepared remarks, we'll be happy to take your questions. I'll now turn the call over to Jeff.

Thanks, Katy. Good morning, everyone. As we open 2023, we're encouraged by our improving business results this quarter. We saw sequential improvement in many leading indicators of underlying demand and easing environmental factors that pressured our business in 2022. While we expect macro factors to persist, Elanco is making a necessary disciplined decision to stabilize the business and progress our innovation pipeline while focusing on improving our cash flow generation and returning to constant currency sales growth in the second half of this year. Beginning on Slide 4. This year is off to an encouraging start. Improvement in our underlying business, notably in pet health increases our confidence in the outlook for the first half and full year of 2023, allowing us to raise the bottom end of the guidance range for our key metrics. We progressed important operational and pipeline milestones and reduced uncertainty in key areas, including the completion of the Bayer ERP system integration and the positive collaboration and progress with the EPA on Seresto. The pipeline continued to advance with conditional approval of our parvovirus product and initial submission of our IL-31 monoclonal antibody for dermatology. Overall, our pipeline is in an even better position than it was just two months ago. Additionally, we remain confident in our liquidity and the business’s ability to generate cash throughout the year. While our operating cash flow was seasonally lower in the first quarter, we continue to expect improvement throughout the year, leading to approximately $100 million of cash available for debt paydown this year. We remain confident in our position relative to our financial debt covenants and our ability to reduce debt and leverage over time. Finally, while our executive leadership and global team remain committed to near-term delivery, we are also actively planning for the expected launches…

Thank you, Jeff, and good morning, everyone. Today, I will focus my comments on our first quarter adjusted measures so please refer to today's earnings press release for a detailed description of the year-over-year changes in our reported results. Starting on Slide 9. In the first quarter, we delivered $1,257 million of revenue, reported growth of 3% or growth of 6% in constant currency. Price contributed 5% in the quarter. As Jeff referenced, we believe our ERP system integration led to a shift in sales from the second quarter to the first. In February, we assumed this shift would benefit first quarter revenue by $40 million to $80 million. However, we now estimate the shift to be approximately $90 million to $110 million. A few factors drove the revised estimate of the customer-initiated demand shift. First, we believe our customers demonstrated a higher level of sensitivity than we anticipated related to the potential for extended disruption from the system cutover and general supply chain concerns. Additionally, we believe sequentially stronger dispensing at our retail partners contributed to the magnitude of purchases in the U.S. pet health business. We believe estimating the benefit of the shift in sales resulting from the ERP blackout provides important context to better understand the trends in our underlying business performance. Therefore, on Slide 10, we provide our revenue results by business area on a reported and a constant currency basis as well as our estimate for the benefit in the quarter from the ERP blackout. For pet health, constant currency growth was 8% with an estimated benefit of 10 to 12 percentage points from the ERP blackout. In the U.S., pet health revenue grew 12%, including an estimated 12 percentage point benefit from the ERP blackout. The approximately flat underlying business performance was driven by…

Thanks, Todd. While our team is focused on delivering in 2023, we acknowledge the desire to better understand the opportunity for Elanco in 2024 and beyond. We are not giving guidance beyond 2023 today, but I want to provide you with some context on how we're thinking about the future. First, our portfolio outlook is balanced. We expect continued competitive and generic pressure but also anticipate improved supply and stabilization in our base pet health business. Regarding innovation, we expect our parvovirus treatment, Experior, our new OTC products and others will continue to ramp delivering incremental innovation revenue in 2024 on the path towards $600 million to $700 million by 2025. For our four other late-stage assets with blockbuster potential, we're confident in a path towards first half 2024 approvals. However, as we know regulatory time lines are subject to many factors and the competitive landscape is uncertain. We are focused on progressing what is in our control, timely, quality and comprehensive submissions. With that said, we are actively reviewing our launch plans and are focused on speed to market post approval. Based on recent experience with Zorbiumbexacat and parvovirus we expect launches to be around 2 months to 4 months post approval. We have not finalized our launch investment plans. However, we expect more limited incremental spending ahead of launches with consideration for more significant investment post launch. The team is working closely to optimize these U.S. launches and will take a thoughtful approach to staging investment. Finally, with the completion of our ERP integration, we continue to expect to drive additional synergies and reduced project cash needs to less than $20 million next year, contributing to expected improved operating cash flow. We hope this additional context is helpful as you consider the opportunity for Elanco in 2024 and beyond. We are encouraged by the milestones achieved, reduced uncertainty and positive leading indicators and have a balanced outlook for our expected progress in the medium term. With that, I'll turn it over to Katy to moderate the Q&A.

Thanks, Jeff. [Operator Instructions] Operator, please provide the instructions for the Q&A session, and then we'll take the first caller.

[Operator Instructions]. Our first question comes from Chris Schott from JPMorgan. Please go ahead. Your line is open.

This is Ekaterina on for Chris. Thank you, so much for taking my question. So first, on ERP, I think you mentioned the magnitude of the ERP dynamic was greater than you were expecting in the quarter. Can you just elaborate a bit more on how you know that, that was all ERP and maybe not strong underlying kind of demand than you were expecting? How are you approaching, I guess, separating out the ERP piece from just like demand? And then the second question is on channel inventory levels in the quarter. So, some of your competitors have mentioned distributors lowering inventory levels in Q1. So, if you take out all that's happened with the ERP piece for the Bayer product, is this something that you also saw for the Elanco business? And then maybe how did that impact Q1. Thank you, so much. A – Todd Young: Thanks for the question, Ekaterina. With respect to the $90 million to $110 million estimate we’ve provided for the bridging stock ordered by our customers, we’ve done a lot of analysis with respect to both specific orders from our customers and conversations with them, understanding what sales have been in historic periods and then also just looking at underlying demand trends, we’re dispensing data and inventory levels. This number is our best estimate, I’ve also got the benefit of having already seen April sales. So, we feel very good about this $90 million to $110 million, it is a timing issue. This is why we made the decision in February to guide to the first half, understanding that this would be a little noisier than we’d ideally like. But net-net, we feel very good about that, but we are pleased with underlying demand. We think it was higher than what our original estimate was as our customers probably were more concerned they’d be out of product longer than our confidence in the execution we would have, great news for us, execution was on the money. And we had the U.S. up and running by April 10. The rest of the country is staged over the course of April, we’re up, we’re running. We’re shipping product. We’re billing, we’re collecting. So really pleased with how the team executed this ERP cutover. And then with the question on channel inventory, the first part to note, most of the U.S. sales for the Bayer legacy products go directly to our retail customers. So, there’s not much impact on that distributor levels or in the farm channel. Overall, those levels have been consistent with what we have had since the end of Q2 of 2020. But we are attuned to distributors with higher cost of capital, focusing on inventory levels. And so, we factored that into our forward guidance as well.

Our next question comes from Erin Wright from Morgan Stanley. Please go ahead. Your line is open.

As you think about the three companion animal blockbuster products in 2024 to the parasiticide and the dermatology, is the time line still on track? Has there been any changes there? Is there any possibility of expediting those launches? And how are you thinking about your conversations with the FDA just given delays across certain competitor products with the FDA specifically? And what investments, and you kind of touched on this, I think, at the very end, Jeff, but what kind of investments do you need to make from a commercial perspective to roll these out? How should we think about that incremental commercial investment that you need to make in 2024? And can you talk about the strategy around distribution, pricing across parasiticides in derm? Thanks.

Thanks, Erin. It's the right question to ask relative to the timing. What I would say is kind of as we step back and look at the pipeline position, I'd say the following things. And as I mentioned, we're controlling what we can control. First, I think quality of the team. What Allen has done with her and her team, the quality of our regulatory team. Second is the quality of the packages, which we're very confident in. The dialogue with the regulators, I can point to proof points, three approvals here recently, Parvo, USDA, [indiscernible] and Verena FDA, I think the track record and recent success is an example of this team and what they're capable of. I also think we're going into some new spaces, Aaron, maybe for us, but not new spaces for regulatory. So derm with a JAK or an IL-31 short-acting or para, these are new areas. Delays that typically come like we saw with Parvo in new areas. So, I would say our confidence level is on that, the size of pipeline and the size of shots on goal in major markets to us, we sit in a very strong position relative to the number that we do have. Relative to the investment, that's why we wanted to highlight a little bit to give you perspective on '24 as count on, as we've seen with these recent approvals for us, launching 2 months to 4 months after approval, and we believe today, we've got and you've seen it, all the things we're doing to drive today's demand are going to help. So, the physical availability, the share of voice, the launch capabilities with digital, we believe ahead of the launches, we don't see a major step up, Erin, we'll see that major step-up coming after the approvals, and we'll model that accordingly. So that's the update. Again, a lot of progress in the pipeline in a much stronger position than even two months ago with everything that happened this quarter.

Next question comes from Balaji Prasad from Barclays. Please go ahead. Your line is open.

Hi, good morning, everyone. So, a couple of questions on Seresto. If you could maybe elaborate on more with what your discussions with the EPA entail, and have you been able to reconcile your safety methodology with that of the EPA, on the same topic, could you also speak about the covenants and both on the interest rate and the interest coverage and the net leverage ratio and see if there's any kind of situation where Seresto withdrawal, if it comes to it, would impact these covenants? Thank you.

Thanks, Balaji. On Seresto, yes, we've made nice progress from our last update in February, and we'll share that, as I mentioned, we are very pleased with this progress. We aligned with the EPA on EPA's recommendations, which linked to stewardship actions all supporting the continued registration of Seresto. We do expect formal results to be communicated by the EPA in the coming weeks. Again, we're confident in the safety of the profile of the product. We're also appreciative of the raising of the bar for the category overall. I just highlight a little bit on Seresto because it's so important to us, we saw sequential improvement in the quarter. We saw the U.S. after you calculate out for the cut over, the U.S. return to growth. Some of that may be attributed to an earlier season, people coming back to retail, but I also think this increased physical availability was a factor. OUS was down a little bit. It was a strong quarter a year ago as well as some of the inventory management. I kind of step back and say, we sold more than half of our 2022 Seresto in the first three months. So, we like what we see. Again, there's a lot of the season remaining. The engagement with the EPA is positive progress, and we'll wait for the formal results here in the coming weeks.

Balaji, with respect to the debt covenants, we feel very comfortable with our liquidity position, our overall cash flow and how we see business progressing over the next eight quarters. With that, we don't think there's any covenant risk whatsoever, we've laid out all the debt-related metrics on Slide 9 in the appendix of the deck. So that if anyone has questions, you can find all the information there on towers and the like. So, we feel very good about where we stand.

Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.

It looks like the base business is tracking better, but then I'm just really confused around some of the free cash flow and inventory stuff. So, let me be more specific. If base business tracked well and there was another $100 million in revenues pull forward, then why is free cash flow minus $145 million because it should have driven EBITDA as well. And then secondly, on inventory, I'm just -- it's something about the disclosures makes me uncomfortable. Todd, you said Bayer goes straight to retail partners, so no inventory, but the 10-K says ahead of Bayer ERP blackout, there was an additional inventory build as of December 31, and it was further increased in 1Q. So, I guess I don't understand what the magnitude of this inventory is and to what extent is it driving the performance we're seeing right now?

Umer, thanks for the question. With respect to the free cash flow, you'll see that the accounts receivable balance has increased significantly given most of these $90 million to $110 million of sales would have happened in the last couple of weeks of the quarter. And so there wouldn't have been cash flow coming in from those collections, but there is the EBITDA that comes from that revenue being recognized in the quarter. So that's the main driver. And then let's talk about the difference between inventory on our balance sheet and inventory at retail partners. Again, as we communicated, inventory at retail partners low at the end of last year. That's something that was a headwind for our business here. There's certainly more inventory there because of our ERP blackout and the purchases made in the U.S. on that, then let's talk about the inventory on our balance sheet. So again, we had volumes down on farm. We got 5% price. So, with the underlying base business still in decline, but having more price, that's lower volume. When you think about the split on inventory between pet health and farm animal, that helped is generally higher margin, which means its inventory balance on the balance sheet is lower because the cost of goods sold are lower. On the farm side, again, the flip flop occurs, lower gross margin, higher comp value. So, we've got struggles in our farm animal volumes in the U.S. that's driving for the increase in inventory on the balance sheet. You'll see we had pet health inventories actually did reduce. That's in line with expectations of greater sales of the Bayer product in the first quarter, that happened, foreign animal inventories are up. The other item to note is foreign exchange rates. We have a lot of inventory that sits outside the U.S., in Europe with our manufacturing footprint there. As the dollar weakened in the quarter, the balance sheet value of that inventory increased because it's in euro. So again, hopefully, we’ve separated inventory in our balance sheet, inventory at retailers from the numbers. And again, operating cash flow generally in line with where we expected to be in Q1. We still expect $100 million of free cash flow this year to pay down debt.

Our next question comes from Michael Ryskin from Bank of America. Please go ahead. Your line is open.

Great. Thanks for taking my question guys. First, I want to ask about your comments on price. I think you indicated 5% in the first quarter balance between companion and assets. But I think you said for the year, only 2% or more than 2%. That implies very little price for the rest of the year. I'm just wondering what's driving that. Is that lighting up on comps? Is that a negative impact in 2Q because of the ERP, is that type of the map suspension? And then I've got a follow-up.

Sure, Mike. You're right. We've said we'll get more than 2% price for the full year. It was a good first quarter, recognizing 5%. We did get a benefit from those are legacy products where we've taken more price this year coming more in the first quarter, so there would be an expectation to be less in the second quarter.

Any follow-up?

Okay. And then the follow-up. It goes back to the blockbuster product launches for next year. Jeff, I appreciate your comments towards the end of the prepared remarks. That was really helpful, but I wanted to dig a little bit deeper. You talked about first half '24, obviously, January is first half, June is also first half. So, given that we're still early in 2013, you don't have that clarity, just wondering your point on anticipating launching coming 2 months to 4 months post approval. If you've got a scenario where you've got a June approval, 2 months to 4 months puts you much later in the year. Does that change a little bit in terms of your thoughts on ramping, especially for something like the broad-spectrum parasiticide, would you expect pretty major seasonality in the market. You want to be on the market in the first half of the year. So is there any consideration of doing sort of like an at-risk ramp in volumes, in manufacturing, to be ready to launch the day after approval. Is that a possibility? Or is there just a limited room there? Thanks.

The right question, Michael. We are putting a lot of time. As you know, we've invested in talent and capabilities in this area. We're using each one of these launches, Zori and now Parvo to really test all of these capabilities. We brought in Tim Beddington, so there's a lot of concentrated effort on all these scenarios. What I would say is, I'd just highlight a couple of things that are key, I think, as you look at '24, the ramping of all of these approvals we just mentioned. I'll point to Parvo, experience ramping. Those are our first two of the six blockbusters we've talked about, they'll be critical out of the gate. Even point to ad tab, which is a $50 million to $100 million oral OTC space. That's what we see as potential over time with this product. So, ramping first will be the most important critical thing as we go into '24. And then look, we're trying to be balanced and pragmatic here because there's a lot of dynamics, the good news is we've got four shots on goal, all kind of going into different major markets with over the two derm products in Para. I would say specifically to Para, seasonality has become less of a factor. When you start looking at drop shipping increased compliance, there's less of a spring pop as much as if you can get this into a program, it becomes a lot less seasonal. We will launch. We will launch better and with more excellence than we ever have in the company's history, with the right resources, given the market potential, what I tried to do today though is to say most of that investment will come after that two to four months after an approval. That's the setup. But be assured, we've got a lot of interest and focus on this, and we'll keep you updated as we progress.

Our next question comes from Nathan Rich from Goldman Sachs. Please go ahead. Your line is open.

Great. Good morning. Thanks to the questions. Jeff, maybe going back to Seresto, could you elaborate on what you meant by Stewardship actions from the EPA? And while I think it sounds like you expect continued registration for Seresto. Would there be any changes in how you are able to market the product going forward? And then quick follow-up, if I could, on the map holiday. How are you thinking about the impact that, that had on the pet health sales in the quarter? And is that impact contemplated in the $90 million to $110 million range when thinking about the 1Q to 2Q shift?

Yes. Thanks for the question, Nate. We won't elaborate much further other than to say, as I mentioned, on Seresto and EPA, great productive dialogue. A lot that's happened here recently. Formal results will come in the coming weeks. A lot of, I would say, sequential improvement, demand and interest in Seresto, we see no change, if anything, a sequential step up. As I mentioned, it's nice to see the U.S. come back to growth. And that's driven -- that's why it took a little time on U.S. pet health, what Bobby has done increasing retail expertise and capability. When we look at just our overall physical availability going up 17%, we're taking price and we're seeing a lot of loyalty from both the e-comm sector as well as the brick-and-mortar. So, look for more to come. But again, I'll reemphasize the most important point. We're pleased with the EPA's recommended stewardship actions. We won't get into those details now, but we believe they're the right thing for the category for our product and others in collars to support the continued registration of Seresto and raise the bar in the category, that's key. As you look at MAP pricing, I kind of want to step back a little bit. This is minimized advertised pricing. This is used commonly in CPG and retail and been in animal health for a long time. It protects the long-term value of the brand, we extended a map holiday or held off on that to avoid extended disruptions in supply during the cutover. Yes, we did see retailers compete on price, like products like Seresto, and even despite that, Elanco still achieved our 5% price in pet health, really important, I would say. So yes, I do think it was a factor, but we reinstated our MAP policy at the end of April. I can highlight that we are back up to normal operating environment, and we'll continue to stay on that policy as we go through the rest of this year.

And Nate, with respect to the $90 million to $110 million, again, we think there may have been a little more underlying dispensing in Q1. That's why we had our less -- more than our $40 million to $80 million we'd estimated in February. We do expect it reverses, as you saw in Q2, maps back in play, and we're continuing to execute the underlying fundamentals that will drive this category.

Our next question comes from Jon Block from Stifel. Please go ahead. Your line is open.

Thanks guys. Good morning. Jeff, just on the innovation sales, is the $210 million to $250 million -- sorry, $20 million to $50 million still the right number for this year, I might have just missed that. And is there a number for the quarter? And then, Jeff, Seresto, I think, was down 9% normalized for the quarter. Do you still expect that to grow this year, just maybe just a quick tack on, Todd? The updated expectations of price more than two. So, if it's 3%, just throw out a number, it sort of implies volumes came down very modestly since the initial guide because the bottom end of the range came up $30 million, the top end was left unchanged. Is that a fair way to frame it? And if so, was that more of a pet health thing or farm animal thing from your perspective?

Thanks, Jon. No change to our innovation sales, as we highlight, drivers to that will be pet therapeutics, Experior, the OTC products, now we'll have Parva coming in here. We'll be shipping that product in the next couple of weeks. So, everything stay the course. And again, those will all be drivers as we ramp going forward. Yes, Seresto is down. We're still not globally where we want to be in full recovery here with Seresto. As I highlighted in international, a couple of factors, a big 11% growth first quarter last year. So, there's a challenging compare. And we saw internationally, again, the retailer inventory oversight management, they had lower inventory. So those were factors. So again, all the things that we highlighted, we are leaning in with a pretty significant campaign on Seresto here that kicked off in April in the second quarter and some of the increased operating expense is an investment to build on the demand that we've seen pick up on Seresto in Q1. So, we'll keep you updated as we go forward.

And then, Jon, with respect to your question on price, overall, we captured price pretty well across our business, the 1 area where there was softness was U.S. farm where generic competition continues to be a place where price is more challenging to capture. We felt like we retired a lot of risk in Q1, the ERP system up running and executed with no glitches, continued improvement sequentially in the pet health business, and just environment stabilization. So that was the big drivers of raising the bottom end of our guidance. Yes. If we get more price, that would be obviously a positive and we'd be happy to have a lot of different factors between volumes and price across our global business that are embedded in our guidance. We feel good about where we sit in the start to the year.

Our next question comes from David Westenberg from Piper Sandler. Please go ahead. Your line is open.

Hi, thank you for taking my question. Congrats. ERPs are hard. So, I'll just put that out there right away. Can you talk about the methodology in terms of calculating the benefit in ERP? And can you kind of get into details, I mean, what exactly is happening for us Wall Street idiots that really don't know what's going on in the industry from like a nuts and bolts level, like it's going to distributors, it's going to like the main warehouses of vets? I mean, just kind of help us bridge what exactly is happening to get to that to $90 million to $110 million calculation for us. And then I just have a quick second question in terms of the guidance. Are you factoring anything competitively with LIBOR now that it got approval or BI's Triple, I think, is actually now maybe a little bit behind schedule. So, any of the pushes and pulls in the guidance with the competitive factors? Thank you, very much.

Yes. With respect to the $90 million to $110 million, this is an estimate based off talking to our customers, looking at historic sales data and looking at underlying trends with inventory levels and pull out. When you think about it, it's in terms of -- we have our customers that order product every week. And so, we went out and told U.S. customers, both on the farm and pet side, but we'll focus on that because it's the bigger notional number. So, we went and told a big online retailer, we will be not selling new product for the next 10 days, but you'll be back up and running and ordering product on April 10. And that retailer has to make a decision. Do I trust, I'll have that? I need to make my sales. I need to make my cash flows for the quarter. And so, they're evaluating, do they buy enough product for 10 days because they trust us and they buy it for 15 days because they're concerned. So that's sort of the valuation that's happening. If you think about distributor in, let's say, Mexico, and we went to them and said, "You're going to be the 35 country to come up on our ERP implementation, and you're going to be blacked out with no ability to buy product for the next 26 days, do they buy a month's worth of product, they buy six weeks, those sorts of things." So, we get into -- we were confident in our execution. That's why we were at $40 million to $80 million, we think they probably took a little more conservative approach. That's how you get to the $90 million to $110 million. Again, we gave first half guidance back in February because we knew this would be complicated, and we're increasing the bottom end of that first half guidance because the good start we're off due to the year.

Yes. On the guidance, just to build, David, on your second question, yes, we have in our assumptions the competitors from February, that guidance hasn't changed and nothing has changed relative to even the recent news on new approvals coming in.

Our next question comes from Brandon Vasquez from William Blair. Please go ahead. Your line is open.

Thanks for taking my question. A lot of product-specific questions have already been asked. So, I guess one that kind of struck or got my attention was, if I heard you correctly, I think you said you -- macro trends are kind of improving globally. And as you look through the back half of the year, you kind of expect them to continue improving. Just kind of curious if you could talk a little bit about that because I think there's a lot of concern from investors, not just in health, but in general, that macro didn't kind of deteriorate in the back half. So, what are you guys seeing there? And then maybe the follow-up to that is what's your confidence in being able to kind of keep the pricing benefits you are talking about now, if there is a worsening macro environment? Thanks.

Sure. Thanks Brandon. Recall, the back half of last year for us was really ugly. The environment was really tough. We saw lots of pressure across Europe. You had the COVID lockdowns in China that really negatively impacted our business in 2022. So, when we talk about the improving conditions, our question going into this year was, was there going to be this sequential improvement? Where are we going to see customers coming back to the OTC channels for Pet Health products. We have seen that. We feel good about that, and that's what we speak to with respect to improving macro environment. Again, we have got challenges here in our underlying business, as we guide that to down two to four in Q2. So, we are clearly not calling a massive rate recovery, but rather just greater stabilization than we had last year. With respect to the question on pricing, again, the teams have done a very good job of executing price increases to start the year. That's demonstrated in the 5% we have received in Q1. There continues to be a lot of competition in the marketplace, and a lot of underlying dynamics we are focused on, that's why we've said, more than 2% for the full year and the teams continue to do well to ensure they are capturing as much of that as they can.

Our next question comes from Steve Scala from TD Cowen. Please go ahead. Your line is open.

Hi. This is Chris on for Steve. I have two questions, both on parvovirus. So first, do you expect any capacity constraints on the U.S. march? And then second, what is the timeline forex U.S. markets? And how should we think about the U.S. versus ex-U.S. split behind the $100 million that would guide on that product? Thank you.

Yes, Chris. Thank you. We are excited about the parvovirus. We will shipping products in the next couple of weeks. We expect about 70% we need state approvals now that will follow this federal conditional approval, we expect about 70% of the states to be in the first month. So, we will be shipping in the next couple of weeks as states come on. Yes, excited about having our first monoclonal antibody plant now with Kansas approved, and would emphasize that, we will plan to be ramping, but as we move from a smaller leader to a higher leader capacity, that will happen throughout the second half of the year. So, the launch will be limited initially by capacity. The net interest is high. I also want to just take this moment to highlight, this is a conditional approval. This will not be at all commercial limiting to us. It really comes as a regulatory body like the USDA in this case sees 330,000 cases a year, a parvovirus is 90% plus mortality from this virus and zero dogs dying in our trial. Let's accelerate this product in the market. We will continue with full approval, but there is really no restrictions here with the conditional approval other than there is a high need, there is a high net interest we will ramp throughout the second half and be in a really strong supply situation as we end this year.

With that, I will just make a couple quick closing comments. Thank you for great questions today and continue to invest our interest. Elanco looks at this quarter and say we're doing this one quarter at a time. We are not where we want to be yet. But I think this quarter showed necessary actions, disciplined decisions, a lot of progress and proof points, as we look at the overall business and what's critical. Overall engagement, Elanco is growing on the inside. Our focus is high. And I would say, the headline here is, we are tracking to our expectation. We are seeing nice sequential improvement coming out of Q4 areas that are stabilizing some areas returning to growth. I would point specifically that, the retiring of risk that we saw not only in the first three months but the first four months around the stand up of our IT system, around Seresto and the overall management of the business, as well as the market that matters most to us as U.S. Pet Health, the lead indicators are driving the lag indicators that's going to set this business up for long-term success. As well as then -- in innovation, launching four products having three approvals, two of our six blockbusters now in the marketplace, and our last major blockbuster initial submission made. So, we still have a challenge here in Q2. We expect to return to growth in the second half. And be assured we are focused right now on what we can control and that is execution across this company. We look forward to fielding questions throughout the quarter from all of you. Thank you for your continued interest in Elanco. Have a great day.

This concludes today's conference call. Thank you for your participation. You may now disconnect.